neuromodulation in substance use disorders

Conditions: Substance Use Disorder

Summary: the primary objective of this study is to assess the safety and feasibility of fus neuromodulation in participants with oud and/or other suds.

this is an open-label early feasibility study investigating low intensity fus targeting the nac/vc for participants with oud and/or other suds. once participants are deemed eligible following screening/baseline, participants will undergo fus in the bilateral nac/vc with behavioral and substance craving assessments performed prior to, during, and following the treatment. participants will be assessed during follow-up visits on day 1, week 1, 4, 8, and 12.

Eligibility criteria:
inclusion criteria: * aged 22 - 60 years at time of enrollment. * fulfill current dsm-5 diagnostic criteria for oud and/or other suds with at least a 2-year history. * currently receiving outpatient treatment from the wvu comprehensive opioid addiction * treatment program (coat), intensive outpatient program (iop) or any other program which implements the coat model; or receiving outpatient/inpatient/residential treatment from similar sud treatment programs. * currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers. * agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event. exclusion criteria: * unable to undergo mr-imaging because of non-mr compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia). * history of any clinically significant neurological disorder. * history of stroke or brain lesion with observable structural abnormalities in the targeted brain region. * clinically significant mri abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments. * an abnormal screening result that is considered clinically significant by a medically qualified research team member (i.e., laboratory tests, imaging findings). * more than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. * past or present diagnosis of schizophrenia or psychotic disorder (assessed via scid- * history of medically verified suicide attempt within the past year. * meet the criteria for cluster a or b personality disorders (assessed via scid-5-pd). * current substance use treatment mandated by court of law. * subject who is currently participating in another clinical investigation with an active * treatment arm. * subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator